Mazor X System

GUDID 07290115751376

MAZOR ROBOTICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290115751376
• NIH Device Record Key: c21ae871-6a58-49bf-a2bd-34a50d08cf1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X System
• Version Model Number: TPL0059-09
• Company DUNS: 532681590
• Company Name: MAZOR ROBOTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115751376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203005

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-01-06

On-Brand Devices [Mazor X System]

• 07290109183213: TPL0059-06
• 07290109181158: TPL0059-05
• 07290109180465: Mazor X System
• 17290109180465: TPL0059-03
• 07290109184838: TPL0059-08
• 07290109184098: TPL0059-07
• 07290115751376: TPL0059-09